Cardiol Therapeutics

A leader in the research and commercial development of pharmaceutical cannabidiol products and targeted therapies for heart failure and cancer.

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Overview

Cardiol Therapeutics Inc. (TSX:CRDL;OTCQX:CRTPF) (Cardiol or the Company) is a biotechnology company focused on developing proprietary formulations that will treat some of the most life-threatening diseases in the western world. The Company is investigating targeting drugs to the heart to treat diastolic heart failure, including the use of highly purified pharmaceutically-manufactured cannabidiol (CBD). CBD has anti-inflammatory and anti-fibrotic properties and has demonstrated evidence of safety and efficacy in clinical trials of certain severe epilepsies.

Cardiol is developing unique manufacturing expertise in the production of pharmaceutical cannabinoids in support of its nanotherapeutics program in heart failure. With the de-scheduling of cannabinoids from the federal Controlled Drugs and Substances Act, the Company believes there is a significant opportunity to manufacture and commercialize a line of pharmaceutically manufactured pure cannabidiol products during 2019 in the growing market for medical cannabinoids.

Cardiol has formed exclusive partnerships with Noramco and Dalton Pharma Services, both of which are FDA-certified and working under GMP standards, to manufacture CBD at >99.5% purity and less than 10 ppm THC. These companies have been instrumental in developing Cardiol’s pharmaceutical CBD products and in working to produce them at scale. Through these partnerships, Cardiol plans to develop and commercialize one of the most advanced formulations of pharmaceutical CBD during 2019, leading a market that is now estimated to exceed $600 million in Canada alone. These agreements also provide the Company with a proprietary supply chain through multiple distribution points, including online, government stores, bricks and mortar locations, and national pharmacies.

In collaboration with researchers and opinion leaders at international centers of excellence, including the University of Alberta, the Houston Methodist DeBakey Heart & Vascular Center, and TecSalud del Tecnológico de Monterrey, Mexico, Cardiol is leveraging multidisciplinary expertise in drug delivery, drug formulation, nanotherapeutics, cardiac physiology, and heart failure. The Company’s research collaborations provide Cardiol with the optimal platform on which to pursue the commercial development of new therapies for heart failure.

Cardiol is developing a high-value portfolio of patented nanoformulations of pharmaceutical CBD and other anti-inflammatory drugs into clinical trials during Q2, 2019. These nanoformulations have been shown to deliver drugs to inflamed tissue in the heart in a pre-clinical model of heart failure, a leading cause of death and disability in the western world.

The Company’s management team has extensive experience in the research and commercial development of novel therapeutics. Additionally, management is notably invested in the Company, holding approximately 35 percent of the outstanding shares.

Company Highlights

  • Implementing nanotechnologies to deliver CBD and other anti-inflammatory drugs for the treatment of diastolic heart failure.
  • Commercializing one of the most advanced formulations of pharmaceutical cannabidiol at >99.5% purity and less than 10 ppm THC during 2019 – a market estimated to exceed $600 million in Canada alone.
  • Research programs at the University of Alberta, the Houston Methodist DeBakey Heart & Vascular Center, and TecSalud del Tecnológico de Monterrey, Mexico.
  • Exclusive partnerships with Dalton Pharma Services and Noramco.
  • Management holds approximately 35 percent of the Company’s shares.

Pharmaceutically Manufactured CBD

In collaboration with Dalton Pharma Services, Cardiol is developing unique manufacturing expertise in the production of pharmaceutical cannabinoids in support of its nanotherapeutics program in heart failure. With the de-scheduling of cannabinoids from the federal Controlled Drugs and Substances Act, the Company believes there is a significant opportunity to manufacture and commercialize pure pharmaceutical cannabidiol regulated by the federal Cannabis Act. Cardiol is developing cannabidiol products that are >99.5 purity and TCH free (less than 10 ppm). The Company plans to introduce a cannabidiol oil product in 2019 and in H2, 2019 a water-like cannabidiol in a sublingual spray for ease of administration.

The market for medical cannabinoids

According to a report by New Frontier Data, the Canadian cannabis market is expected to reach $9.2 billion by 2025. Part of this growth is being driven by the advances in medical applications of CBD as more research is conducted into its beneficial effects. The growth will also be driven by the need to find an alternative to using opioids, which can be highly addictive, to treat chronic pain.

Heart Failure Program

People with heart failure suffer from a variety of ailments, including shortness of breath, rapid heart rate, edemas, reduced exercise capacity, can often struggle with simple daily activities, and are frequently hospitalized. Many of these symptoms can significantly reduce the quality of life for an individual.

There are two types of heart failure: systolic and diastolic. Systolic heart failure, or heart failure with reduced ejection fraction (HFrEF), occurs when the left ventricle cannot adequately pump blood from the heart and into circulation. Diastolic heart failure, or heart failure with preserved ejection fraction (HFpEF), occurs when the left ventricle becomes stiff and doesn’t relax as it should and, as a result, cannot fill properly, causing pressure to build in the left side of the heart and in the lungs. This results in a patient feeling shortness of breath and is associated with health concerns such as obesity, hypertension and diabetes.

Another complication that can be experienced by those suffering from HFpEF is chronic inflammation, which can lead to a decrease in blood vessel function, impairment of heart muscle function and fibrosis, which results in stiffness in the heart and a reduction in pumping efficiently. Over the past 20 years, there have been little to no significant treatments developed for HFpEF, as therapies have primarily remained focused on diuretics.

The market

More than 26 million people across the globe are affected by chronic heart failure. Of this number, six million are based in Canada and the US, making heart failure a leading cause of death and hospitalization in the region. In the US alone, the associated health costs exceed $30 billion annually.

To combat the effects of heart disease and to create a better quality of life for patients, Cardiol is developing a portfolio of patented, innovative nanotherapeutics that utilize anti-inflammatory drugs to treat cardiac tissue that is experiencing inflammation and fibrosis.

Products

CTX01

CTX01 is a proprietary formulation of pharmaceutical cannabidiol being developed for the treatment of heart failure with preserved ejection fraction.

Published third-party research has shown that cannabidiol reduces inflammatory activation of the endothelial lining of blood vessels and aids endothelial vasorelaxation, resulting in improved blood flow. Cannabidiol has also been shown to attenuate a number of m

easures of inflammation in models of diabetes, a common co-morbidity in heart failure patients, and to reduce myocardial fibrosis in a model of inflammatory heart disease.

Cannabidiol is lipid soluble, virtually insoluble in water, highly sensitive to deactivation in the liver via first-pass metabolism and is rapidly cleared from the body. This results in low active blood levels and overall bioavailability of less than 10% when taken orally. Cardiol’s CTX01 formulation for subcutaneous administration is designed to avoid first-pass metabolism, optimize and maintain blood levels of the drug, and target cannabidiol to areas of inflammation and increased fibrosis in the heart. Cardiol believes that overcoming the low bioavailability issues associated with cannabidiol and targeting the drug to sites of disease, will significantly broaden the therapeutic potential of this molecule.

CTX02

CTX02 is a proprietary formulation of methotrexate, an inhibitor of cell division originally developed for cancer therapy, for the treatment of heart failure. Recent experimental studies indicate that methotrexate can improve cardiac function after acute myocardial infarction and has anti-fibrotic properties. Currently, low dose methotrexate is being investigated to determine whether its anti-inflammatory effects will lead to a reduction in serious cardiovascular events. The results of this study will have an impact on the treatment options made available for patients with heart failure.

CTX03

CTX03 is a proprietary nanoformulation of encapsulated cyclosporine A (CsA), an immunosuppressant commonly used for the prevention of organ transplant rejection, that is being developed by Cardiol to treat heart failure. Current evidence suggests that the action of CsA reduces the rupture of the mitochondrial membrane, thereby reducing cell death and, in the heart, death of heart muscle cells (cardiomyocytes)

Cardiomyocyte cell death is an important component to heart failure and can cause irreparable damage. Cardiol aims to use nano-encapsulated CsA to target the drug directly to the failing heart.

Patented nanotechnology for drug formulation and delivery

Most drugs in development are fat-soluble, making them incompatible with water-based blood circulation. In order to address this limitation, Cardiol has developed a patented nanotechnology solution that combines a fat-compatible core with a water-compatible shell. These combined features and the polymeric nanostructures are designed to enhance solubilization of fat-soluble drugs, enhance circulating drug levels and target drugs to the specific sites of disease.

Work conducted in an experimental model of heart failure by the Houston Methodist DeBakey Heart & Vascular Center has shown that Cardiol’s nanotechnology preferentially accumulates, particularly when it comes to heart inflammation. The nanotechnology is designed to target sites of inflammation and there is potential for it to direct drugs to the sites of disease.

Strategic Partnerships

Dalton Pharma Services

Cardiol has established an exclusive manufacturing arrangement with Dalton Pharma Services (Dalton) for supplying pharmaceutical cannabidiol at >99.5% purity for Cardiol’s research programs.

Located in Toronto, Canada, Dalton is a Health Canada approved, FDA registered, cGMP manufacturer of over 200 Active Pharmaceutical Ingredients (APIs), including pharmaceutical cannabinoids, with manufacturing capability scalable to support all stages of the regulatory process (Phase I, II, III and commercial). In 2016 and 2017, Dalton Pharma Services received the Leadership Award for Contract Manufacturing Organizations (CMO) in the following categories: Quality, Capabilities, Expertise, Compatibility, and Development.

Dalton is also the manufacturer of Nabilone, the largest prescription pharmaceutical cannabinoid in the world, with annual sales of $100 million in Canada alone.

In collaboration with Dalton, Cardiol is developing unique manufacturing expertise in the production of pure pharmaceutical cannabinoids in support of its nanotherapeutics program in heart failure. With the de-scheduling of cannabinoids from the federal Controlled Drugs and Substances Act, Cardiol believes there is a significant opportunity to manufacture and commercialize pure pharmaceutical cannabidiol regulated by the federal Cannabis Act.

As part of the partnership, Dalton is also a significant shareholder in Cardiol. Dalton’s founder, owner and CEO, Peter Pekos, is on Cardiol’s board.

Noramco

Noramco is a global leader in the manufacturing and supply of controlled drug substance APIs. Noramco is one of the largest FDA-certified and GMP manufacturer of pharmaceutical CBD and controlled drug substances in the world.

Cardiol has an exclusive supply agreement with Noramco to manufacture and supply pure pharmaceutical CBD in Canada and Mexico. By 2019, Noramco’s manufacturing capacity will reach at least one tonne of pure pharmaceutical CBD per year, which it will supply to Cardiol. With an average retail price for CBD of $100 per gram, this places the retail value of Noramco’s production at over $100 million. By 2020, Cardiol’s supply chain production capacity is expected to exceed 5 tonnes per year.

The agreement with both Noramco and Dalton provides Cardiol with an exclusive supply chain to manufacture and support entering into the Canadian medical cannabinoid market. The growing market for medical cannabinoids in Canada is projected to reach $2.31 Billion by 2021 (Source: New Frontier Data). As of 2018, all CBD products sold in Canada contain THC. With Cardiol’s entrance to the medical cannabinoid market, safety-focused consumers will be able to receive the relief that CBD provides without THC.

Cardiol Therapeutics

Research Collaborations

University of Alberta

Cardiol’s research program at the University of Alberta is focused on the development of proprietary nanoformulations of anti-inflammatory drugs designed to enhance the compatibility of drugs with the aqueous blood circulation, improve pharmacokinetics, and increase drug concentration at the site of disease.

The Company’s research program is being conducted under the direction of Dr. Afsaneh Lavasanifar, Professor in the Pharmaceutical Sciences at the University of Alberta, and a recognized expert in pharmaceutics, nanomedicines, and drug formulation.

In 2007, the University of Alberta and the Government of Canada collaborated to create the National Institute of Nanotechnology, the mission of which is to transform nanoscience ideas into novel, sustainable nanotechnology solutions.

DeBakey Heart and Vascular Center

Cardiol is conducting experimental research at the Houston Methodist DeBakey Heart & Vascular Center, designed to investigate the activity of the Company’s proprietary nanotechnology in a model of non-ischemic cardiomyopathy.

The Houston Methodist DeBakey Heart & Vascular Center is recognized internationally as a center of excellence for the treatment of heart failure. The center was the birthplace of cardiovascular bypass surgery in 1964 and is currently ranked the 14th best hospital for care in cardiology and heart surgery out of 5,028 hospitals in the United States.

TecSalud del Tecnológico de Monterrey

Cardiol is collaborating with TecSalud del Tecnológico de Monterrey (TecSalud) on research and development of proprietary nanotherapeutics for the treatment of heart failure. The primary objective of this collaboration is to develop the experimental evidence necessary to support advancing breakthrough nanomedicines for heart failure into clinical development during 2019.

TecSalud is committed to delivering outstanding patient care with four cutting-edge academic medical centers that combine innovative research, clinical services, and education.

TecSalud has collaborative relationships with the Houston Methodist DeBakey Heart & Vascular Center and the University of Calgary and has established a formal agreement with the Massachusetts Institute of Technology (MIT) to promote research and development in nanoscience and nanotechnology in Mexico.

Management

David Elsley, MBA — President and CEO

Founder and CEO of Vasogen Inc., with 25 years experience developing, financing and managing all aspects of corporate development of biotechnology and high-growth organizations.

Eldon R. Smith, OC, LLD (Hon), MD, FCAHS, FCCS, FRCPC — Chief Medical Officer and Chairman

Cardiologist; former Head of Cardiology, former Chairman of Medicine, former Dean of Medicine, University of Calgary;

Chair Steering Committee, Canadian Heart Health Strategy; recipient of Order of Canada.

Chris Waddick, MBA, CPA — CFO

Thirty years of experience in financial and executive roles in the biotechnology and energy industries, former Chief Financial Officer and Chief Operating Officer of Vasogen Inc.

Anthony E. Bolton, B.Sc., Ph.D., D.Sc. — Chief Scientific Officer

Immunologist, 20+ years experience in biotechnology, Chief Scientific Officer of Vasogen Inc.; former Professor and Department Head of Biomedical Sciences, Sheffield, UK.

Anne Tomalin, BA, B.Sc., RAC — Director of Regulatory Affairs

Founder of CanReg Inc and TPIreg, regulatory firms previously sold to Optum Insight and Innomar Strategies respectively. An expert in regulatory affairs in Canada, United States and Europe.

Blagoja Ristevski, B.Sc., CHE — Director of Chemical Engineering and Manufacturing

Chemical Engineer, 25+ years experience in the biopharmaceutical industry, senior exec. roles in eight Canadian biopharmaceutical Co.’s in the research/discovery of drug products; VP Product Dev., AMRIC Institute, Ontario, Canada.

Dolly Kao, B.Sc., JD — Intellectual Property Counsel

Co-Founder of PCK LLP. Highly experienced IP lawyer with a practice focused primarily on patent and trademark matters (procurement, oppositions, and opinions) for clients in the chemical, pharmaceutical, and biotechnology industries.

Guillermo Torre-Amione, MD, Ph.D. — Director

President of TecSalud academic medical center and school of the Instituto Tecnológico y de Estudios Superiores de Monterrey (ITESM), Mexico. Former director of Cardiac Transplantation at the Houston Methodist DeBakey Heart & Vascular Center.

Deborah Brown, MBA — Director

Partner at Accelera Canada with multiple years advising pharmaceutical clients in strategy and initiatives, market research, market access and regulatory affairs. Previously President, EMD Serono Canada (division of Merck KGaA, Merck Serono).

Peter Pekos, B.Sc., M.Sc. — Director

President, CEO and Founder at Dalton Pharma Services with broad experience in the research, development and commercialization of pharmaceuticals, products and services.

Terry Lynch, B.BA. (Hon) — Director

Chairman, Chilean Metals Inc., Founder of Pallet Pallet and Partner with Kingsmill Capital; entrepreneur with extensive experience and expertise in financing the development of new technologies.

Iain Chalmers, MBA — Director

Strategic Marketing and Innovation. Former Vice-President marketing and innovation at Diageo, the world’s largest spirits company. Professor of Marketing at Centennial College Business School.


 

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